Norton Performance Plastics Corp.: FDA clearances and approvals
Norton Performance Plastics Corp. has 39 FDA 510(k) clearances (first 1977, latest 1985), across 17 product codes in 3 review panels. Median 510(k) review time: 37 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 6 | 6 |
| DQO | Catheter, Intravascular, Diagnostic | 4 | 4 |
| DRS | Transducer, Blood-Pressure, Extravascular | 4 | 4 |
| FMG | Stopcock, I.V. Set | 4 | 4 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 | 2 |
| DYG | Catheter, Flow Directed | 2 | 2 |
| GAZ | Tubing, Noninvasive | 2 | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
Plus 7 more product codes.
Review panels
Most recent Norton Performance Plastics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853791 | NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 | DTR | 1985-12-09 | 89 |
| K852914 | ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION | DQY | 1985-09-25 | 77 |
| K851299 | CORRECT FLO | FPA | 1985-05-07 | 36 |
| K842858 | FLUID ADMINISTRATION LINE W/SPIKE 14-923 | FPA | 1984-09-11 | 50 |
| K841828 | CENTRAL VENOUS CATHETER W/BIG-GARD | DQY | 1984-07-13 | 71 |
| K840240 | MICROFUSE INTRAVENOUS CATHETER SET | DQY | 1984-04-17 | 88 |
| K831587 | TEMP. REPAIR KIT-DUAL LUMEN CATHETER | LJS | 1983-10-19 | 155 |
| K831698 | DISPOSABLE PRESSURE TRANSDUCER#14004195 | DRS | 1983-08-11 | 78 |
| K830788 | CENTRAL VEIN CATHERIZATION KIT-14-690- | DQO | 1983-04-30 | 47 |
| K830813 | FRENCH PERCUTANEOUS SHEATH INTRODUCER | DYB | 1983-04-28 | 45 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Norton Performance Plastics Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Norton Performance Plastics Corp. have?
Norton Performance Plastics Corp. has 39 FDA 510(k) clearances (first 1977, latest 1985), across 17 product codes in 3 review panels.
How long does FDA take to clear Norton Performance Plastics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Norton Performance Plastics Corp.'s cleared 510(k)s is 37 days.
What devices does Norton Performance Plastics Corp. make?
Its most frequent FDA product codes are DYB (Introducer, Catheter, 6); DQO (Catheter, Intravascular, Diagnostic, 4); DRS (Transducer, Blood-Pressure, Extravascular, 4).
Has Norton Performance Plastics Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Norton Performance Plastics Corp. Related entities may recall under other names.
Next steps
- See all 39 Norton Performance Plastics Corp. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Norton Performance Plastics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.